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Study of Drug Combination Treatment (Capecitabine, Oxaliplatin, Fluorouracil, Irinotecan) Guided by Liquid Biopsy Testing in Patients with Stage III and High-Risk Stage II Colon Cancer

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What is this study about?

This study focuses on patients with colon cancer, specifically those with stage III or high-risk stage II disease who have undergone surgery. The study aims to determine if a special blood test called liquid biopsy can help guide treatment decisions after surgery. This test looks for small pieces of tumor DNA in the blood to monitor if the cancer might return.

The treatment plan includes several anti-cancer medications that work in different ways to fight cancer cells. These medications are capecitabine (taken as tablets by mouth), oxaliplatin (given through a vein as an infusion), fluorouracil (given through a vein), and irinotecan (given through a vein as an infusion). The specific combination of these medications will be determined based on the results of the blood tests.

Throughout the study, participants will have regular blood samples taken to check for signs of cancer using the liquid biopsy test. They will also have routine medical check-ups and imaging tests to monitor their health. The study will track how well patients do over time, particularly focusing on whether they remain cancer-free for two years after their surgery.

1 Initial assessment

Confirmation of stage III or high-risk stage II colon cancer diagnosis through tissue examination

Verification of normal organ functions

Assessment of physical condition using ECOG performance scale (measure of daily living abilities)

Collection of blood sample for liquid biopsy (blood test to detect cancer DNA)

2 Treatment preparation

Review of original tumor tissue sample results

Completion of quality of life questionnaires (QLQ-C30 and CR-29)

For women of childbearing age: pregnancy test and discussion of contraception methods

3 Treatment administration

Receipt of medications through different methods:

Capecitabine: tablets taken by mouth

Oxaliplatin: medicine given through vein infusion

Fluorouracil: medicine given through vein injection or infusion

Irinotecan: medicine given through vein infusion

4 Monitoring period

Regular blood samples for liquid biopsy testing

Assessment of treatment side effects using standard criteria

Regular physical examinations and imaging tests

Completion of quality of life questionnaires at specified intervals

5 Follow-up period

Continued monitoring for up to 2-3 years

Regular assessments to check for signs of disease

Final evaluation at study completion

The study continues until July 2027

Who Can Join the Study?

  • Must sign written informed consent for the Pegasus trial
  • Must be 18 years or older
  • Must have confirmed stage III or T4N0 stage II colon cancer that is:
    – Located at least 12 cm from the anal opening
    – Above the peritoneal reflection (outer lining of the abdomen)
    – Suitable for surgery
  • Must have available FFPE tumor tissue (tumor sample preserved in paraffin wax)
  • Must have blood plasma sample collected before surgery
  • Must agree to undergo all required liquid biopsies (blood tests to detect cancer cells)
  • Must have good physical function (ECOG performance status 0-1), meaning able to carry out all or most daily activities
  • Must have normal organ function
  • For women who can become pregnant:
    – Must complete a pregnancy test
    – Must agree to use reliable birth control methods

Who Cannot Join the Study?

  • Age below 18 years or above 75 years
  • Previous diagnosis of any other type of cancer in the past 5 years (except for adequately treated non-melanoma skin cancer or cervical cancer in situ)
  • Presence of metastatic disease (cancer that has spread to other parts of the body) at diagnosis
  • Inability to undergo surgery for colon cancer
  • Presence of microsatellite instability (MSI) in tumor tissue (a specific genetic characteristic of the tumor)
  • Pregnancy or breastfeeding
  • Severe mental illness that could affect the ability to provide informed consent
  • Participation in other clinical trials within 30 days before enrollment
  • Known allergy or hypersensitivity to study medications
  • Significant heart, liver, or kidney disease that could interfere with study participation
  • Inability to provide blood samples for liquid biopsy (a blood test that looks for cancer cells or cancer DNA)
  • Lack of willingness to follow study procedures and follow-up visits

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Hospital Del Mar Barcelona Spain
Hospital Santa Maria Della Misericordia Perugia Italy
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
IRCCS Ospedale Policlinico San Martino Genoa Italy
Instituto de Investigacion Sanitaria Fundacion para la Investigacion del Hospital Clinico de Valencia-INCLIVA Valencia Spain
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Imblwslf Cqtayk Dpfhjzheobixixwwx L'hospitalet De Llobregat Spain
Hijlkbqz Vfkx dpjxawui Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Not recruiting
03.07.2020
Spain Spain
Not recruiting
03.07.2020

Trial locations

Investigated drugs:

Based on the provided trial data, I cannot identify any specific medications or therapies to list, as the source information focuses on a clinical trial studying liquid biopsy (a diagnostic procedure) in colon cancer patients. The trial appears to be an observational study of using blood tests (liquid biopsy) to monitor cancer patients after surgery, rather than testing specific medications or treatments.

The trial’s focus is on monitoring circulating tumor DNA (ctDNA) in blood samples to guide post-surgical management of colon cancer patients, but no specific medications or therapeutic interventions are mentioned in the provided data.

If you have additional information about medications or therapies used in this trial, please provide it for a complete response.

Investigated diseases:

Colon cancer – A disease that begins in the large intestine (colon), where healthy cells in the colon start to grow uncontrollably and form tumors. It typically develops slowly over several years, often starting as small, noncancerous clumps of cells called polyps. The cancer usually affects the inner wall of the colon first, and as it grows, it can spread through the different layers of the colon wall. The disease can develop in any part of the colon, which is the final part of the digestive tract. When caught early, the disease is often confined to the colon, but over time it can spread to nearby structures and other organs.

Trial ID:
2024-517704-10-00
NCT ID:
NCT04259944
Trial Phase:
Therapeutic exploratory (Phase II)

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